ROLE
– Scientific review of external API vendor’s DMFs in context of global ANDA/NDA & resolving any gaps.
– Preparation & review of ANDA/NDA Drug Substance Modules for submission to FDA & related activities.
– Participation in project meetings, coordination with CFTs, effective communication & coordination.
– Supporting Europe & Canada market projects for Drug substance part, as required.

REQUIREMENTS
– Knowledge of current regulatory guidelines is required.
– Experience of complex APIs will add value.
– Knowledge of using AI in routine work will add value.
– Local candidate is preferred.